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Recruiting Not applicable NCT07126470

Impact of Capsular Tension Ring on Intraocular Lens Position in Retinitis Pigmentosa Cataract Patients

No applicable phase (e.g. observational)
Conditions: Cataract Retinitis Pigmentosa (RP)

Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

trial.available_in: БГ
Overview
This is a self-controlled randomized clinical trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) position in cataract patients with retinitis pigmentosa(RP). Each patient will receive CTR implantation in one eye, with the fellow eye serving as control. Postoperative outcomes, including visual acuity, IOL position, and postoperative complications will be compared between eyes.
Description
Patients with retinitis pigmentosa (RP) have a higher risk of developing cataracts, often accompanied by abnormalities such as zonular laxity and vitreous liquefaction, which increases the risk of intraocular lens (IOL) tilt, decentration, and capsular contraction after surgery. The capsular tension ring (CTR) can support the zonules and maintain the stability of the capsular bag, but its effect in RP patients remains controversial. In this self-controlled clinical trial, we are going to recruit 88 RP patients scheduled for bilateral cataract surgery. Both eyes receive a monofocal DCB00 IOL, while only on eye receives an additional CTR. Follow up visits take place 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively. At the follow up visits, IOL decentration and tilt (determined by anterior segment SS-OCT Casia 2), visual acuity, and postoperative complications will be compared intraindividually at different timepoints.
Who can participate
Inclusion Criteria: * Age ≥ 18 years. * Clinical diagnosis of retinitis pigmentosa (RP). * Bilateral cataract meeting the indications for IOL implantation. * Willingness to participate in the study and provision of signed informed consent. Exclusion Criteria: * History of intraocular surgery. * Severe zonular weakness (e.g., zonular dialysis \>90°, lens subluxation/dislocation) * Other ocular comorbidity: such as pseudoexfoliation syndrome, ocular trauma, corneal dystrophies, uveitis, etc. * Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.
Interventions
CTR implantation
PROCEDURE
Locations 3
China (3)
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou , Guangdong
Shenzhen Eye Hospital
Shenzhen , Guangdong
NOT_YET_RECRUITING
Wuhan Aier Eye Hospital
Wuhan , Hubei
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
25.08.2025
Completion date
01.08.2027
Registry ID
NCT07126470
Source
clinicaltrials.gov
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